Department of Health and Human Services September 1, 2005 – Federal Register Recent Federal Regulation Documents
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National Library of Medicine; Request for Nominations
The National Institutes of Health (NIH) is issuing this notice to invite private sector providers and users of chemical information to indicate their interest in participating in a new working group of the Board of Scientific Counselors of the National Center for Biotechnology Information (NCBI), National Library of Medicine (NLM), to advise on interactions with private sector information providers in the development of PubChem. PubChem is a publicly available NIH database that includes information about the biological activities of chemical compounds. It is designed to facilitate more integrated access to these information resources for biomedical researchers. The working group will advise on such issues as improving connections with private sector chemical information providers in order to enhance linkages and interoperability among resources and avoid unnecessary duplication with commercial information services. Response Date: Persons, groups, or organizations interested in participating in the working group should send an e-mail indicating their expertise in issues related to PubChem, along with their contact information, to: Christine Ireland, Committee Management Officer, NLM, irelanc@mail.nih.gov. Emails must be received on or before October 3, 2005. Supplementary Information: In 2004, as part of the NIH's Roadmap Initiative to speed new medical treatments and improved health care to all Americans, NIH launched an on-line database called PubChem as part of an integrated suite of databases supporting the New Pathways to Discovery component of the Roadmap effort. New Pathways focuses on very basic biomedical research, and especially focuses on understanding the molecular biology of health and illnesses. Bioinformatics is a critical component of that effort and PubChem provides the free, publicly available database that links chemical information with biomedical research and clinical information. Drawing from many public sources, PubChem organizes information about the biological activities of chemical compounds into a comprehensive biomedical database. All of this supports the part of the Roadmap called the Molecular Libraries initiative. This includes nine different componentsa compound repository, the NIH Chemical Genomics Center, the Molecular Libraries Screening Center Network, PubChem, a series of Cheminformatics Research Centers, and technology development for chemical diversity synthesis, assay development, instrumentation, and toxicology. PubChem is the informatics backbone for virtually all of these components, and is intended to empower the scientific community to use small molecule chemical compounds in their research. Small molecules include many of the chemicals commonly used as medicines. They affect genes, proteins, cells, and people. Identification of small molecule tools is a compelling next step following on the success of the Human Genome Project. It offers a new paradigm to transform basic biomedical research, speeding development of new therapies and finding solutions to America's most important health problems. NIH's goals are to rapidly translate the discoveries of the genome into new therapeutics and to integrate small molecule chemistry into biomedical research. PubChem facilitates these efforts by linking genome, chemistry, protein, and biomedical literature information. This seamless integration of resources is essential for providing information about potential starting points for the development of new medications. Without PubChem, the work of NIH funded scientists will be greatly hampered and progress in biomedical research will be slowed. NIH intends to continue to operate PubChem as a free, publicly available resource that is an integral part of the NIH Roadmap Initiative. This is consistent with the principles of publicly funded science. NLM has had extensive and valuable private sector interactions for developing and maintaining other major information resources, such as sequence databases and PubMed/Medline. NIH believes that the private sector has expertise that will be helpful in the further development of PubChem and will help to ensure coordinated and integrated access by researchers to the full range of resources useful for advancing scientific discovery. Therefore, NIH is asking private sector providers and users of chemical information to indicate their interest in participating in a working group of the NLM/NCBI Board of Scientific Counselors, which is established under the Federal Advisory Committee Act. All members of such a working group would be required to disclose their potential conflicts. This new working group of outside experts would be separate from the existing PubChem Working Group, which provides advice about details of the operation of the PubChem database and also reports to the NCBI Board of Scientific Counselors. Specifically, this working group would advise the NCBI Board of Scientific Counselors on such issues as: Establishing a process for retrospective evaluation of the biomedical relevance of compounds entered into PubChem Ensuring the provenance of the data (i.e., whether private data are being improperly deposited in PubChem) Ensuring the high quality of data in PubChem Monitoring the effect of PubChem on scientific progress Improving/integrating interactions with commercial information providers Avoiding unnecessary duplication with commercial information providers
Medicare Program; Medicare Prescription Drug Discount Card; Revision of Marketing Rules for Endorsed Drug Card Sponsors
This final rule will revise the current limitations prohibiting an endorsed drug card sponsor from marketing its Part D plans to its drug card enrollees. This revised rule will give the current drug card sponsors the ability to market to their enrollees Part D plans that are either offered by the same endorsed drug card sponsor or an affiliated organization of the same endorsed drug card sponsor. We are making these changes after considering the public comments received regarding the need to ensure a smooth transition from the drug card to the Medicare Prescription Drug Benefit.
Agency Emergency Processing Under Office of Management and Budget Review; Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). FDA is preparing a guidance document to notify the public of procedures being implemented by the agency to assist firms that wish to request, on a case-by-case basis upon an appropriate showing, an extension to use existing label stock after the effective date of the trans fat labeling final rule. This notice solicits comments on the proposed collection of information associated with the guidance document entitled ``Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006.''
Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product
The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking to request comment on whether to initiate a rulemaking to codify its interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), regarding when an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter (OTC) drug product.
Advisory Commission on Childhood Vaccines; Notice of Meeting
The Health Resources and Services Administration is amending a notice that appeared in the Federal Register of August 22, 2005 (70 FR 48962-48963) announcing an Advisory Commission on Childhood Vaccines meeting on September 14, 2005. The document announced that the public can join the meeting by attending in person or by audio conference call. The meeting will now be held by audio conference call only. This document amends the notice by changing the place of the meeting.
Office of Refugee Resettlement; Final Notice of Allocations to States of FY 2005 Funds for Refugee Social Services
This notice establishes the final allocations to States of FY 2005 funds for refugee \1\ social services under the Refugee Resettlement Program (RRP). The final notice reflects amounts adjusted based upon final adjustments to FY 2002, FY 2003 and FY 2004 (0ctober 1, 2001 through September 30, 2004) data submitted to ORR by States.
Family and Youth Services Bureau; Positive Youth Development State and Local Collaboration Demonstration Projects
Notice is hereby given that a noncompetitive grant supplement is being made to the following state agencies: State of Nebraska Health & Human Services, University of Kentucky Research Foundation, State of Oregon, New York Office of Children & Family Services, State of Louisiana, Iowa Dept. of Human Rights Criminal & Juvenile Justice, Commonwealth of Massachusetts, Illinois Department of Human Services, Governor's Office for Children Youth & Families. The purpose of this supplement is to support collaborations between state-level agencies and local community jurisdictions regarding positive development opportunities available to young people as approved in their original planning grant.
Medicare Program; Establishment of the Medicare Advantage Program
This document corrects technical errors that appeared in the final rule published in the Federal Register on January 28, 2005 entitled ``Establishment of the Medicare Advantage Program.'' It also stays several amendments made in the previous rule.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006; Corrections
This document corrects errors in the proposed rule that appeared in the Federal Register on August 8, 2005 entitled ``Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006.''
Medicare Program; Withdrawal of Ambulance Fee Schedule Issued in Accordance With Federal District Court Order in Lifestar Ambulance, Inc.
This notice with comment period withdraws the fee schedule that was put in place in 2003 to effect compliance with the Order in Lifestar Ambulance, Inc. v. United States. [211 F.R.D. 688 (M.D. Ga. 2003)] That Order was vacated on January 10, 2005 by the U.S. Court of Appeals for the Eleventh Circuit and is no longer in force.
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